Director, Vaccine Clinical Research and Development (MD) in Marlow

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

ROLE SUMMARY

Primary purpose is to serve as a Clinician within a Pfizer vaccine development program. This role may serve as a clinical lead for one or more studies within a clinical program and works closely with the global clinical program lead who is ultimately responsible for execution of the overall program. This role will be set within a matrix team in executing studies, performing medical monitoring, supporting regulatory interaction, and taking on a leadership role in study teams for many of the clinical deliverables. The clinician is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.

RESPONSIBILITIES

• Accountable for safety across the study: Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
• Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP). Perform and document regular review of individual subject safety data, and review of cumulative safety data with the safety risk lead. May delegate these responsibilities to the study clinician scientist identified in the SSRP.
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provide medical context in terms of risk factors, medical history and other factors required to contextualize SAEs or AEs.
• Participate in the Safety Review Team to evaluate medical benefits/risks for targeted indications.
• Review literature as needed to respond to safety questions from Safety Review Team, Data Monitoring Committee (DMC) or others; communicate safety information to sites and respond to safety questions.
• Protocol design and strategy: Provide medical input during development and updates to the clinical development plan. Ensure documents (protocol, Informed Consent Document) meet regulatory requirements and company policy and have IRB/IEC review. Provide medical input into country feasibility. May design development strategies for multiple protocols to obtain worldwide approval.
• Support study team: With supervision of medical monitor provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, and data quality planning. Contribute to CRO/vendor selection to ensure protocol compliance, and data integrity. Ensure high quality data and appropriate patient populations during the study. Contribute to medical review and interpretation of efficacy and safety data; deliver top-line reports with the statistician and clinical study reports with the medical writer; ensure overall quality and timeliness.
• Provide protocol-specific training to study team, investigators, CRAs, and others. Interact with healthcare professionals at sites to enable quality, compliance and patient safety. Interact with DMCs and steering committees as required. Notify study team of changes in research activity and significant new adverse events. Monitor investigator compliance with protocol and regulatory requirements. Support issue resolution, study closeout, audit responses, and inspection readiness.
• Supports the program team: Under supervision, author clinical sections of regulatory documents (Investigator Brochure, Annual Reports, IND sections, clinical study report). May co-author abstracts, posters, presentations, and publications. May contribute to budget execution of protocols. Interact with regulatory authorities and key opinion leaders to build networks for new trials. Collaborate across regions and functions to maintain high-quality data and study delivery.
• Regulatory and external interactions: May support regulatory authority interactions with responses. Liaise with key opinion leaders and principal investigators to expand networks for new trials. Participate in due diligence reviews for in-licensing considerations and support business development on market opportunities and target product profiles. Act as clinical representative in in-licensing activities as applicable.
• Additional program responsibilities: Maintain familiarity with literature relevant to the project; coordinate medical opinions globally; ensure on-time and within-budget execution of protocols; interface with discovery, safety sciences, statistics, regulatory, and other teams as needed. Participate in standing committees and review compounds for potential in-licensing as appropriate.

BASIC QUALIFICATIONS

• Medical degree (M.D./D.O. or equivalent).
• Licensed to prescribe medicines (independent of supervision) for at least one year and has used the license in patient care for at least one year.
• Ability to critically evaluate medical/scientific information.
• Understanding of design, development, and execution of clinical programs and studies.
• Ability to adapt to a fast pace and changing environment.

PREFERRED QUALIFICATIONS

• Documented work experience/knowledge of statistics.
• Training and experience in infectious diseases and/or infection control in the hospital setting.
• Experience with investigational clinical trials.

DIRECTOR LEVEL REQUIREMENTS IN ADDITION TO THE ABOVE INCLUDE:

• Medical degree with valid license for at least 2 years after graduation.
• Proven pharmaceutical industry experience related to clinical research programs and registration activities, preferably for vaccines, or an investigator with significant vaccine trial experience in academic, NGO or public health settings may be considered.
• Training in Infectious Disease, Internal Medicine or Pediatrics preferred.
• Demonstrated diverse leadership capabilities including influencing, coaching, and cross-functional collaboration to achieve outcomes and business impact.

Work Location Assignment: Hybrid (some office presence is required)

Purpose

Breakthroughs that change patients' lives. Pfizer is a patient-centric company guided by the values of courage, joy, equity and excellence. Our digital transformation strategy aims to accelerate drug discovery and development while enhancing health outcomes and patient experience.

Disability and Diversity: Pfizer is committed to diversity and inclusion. We are proud to be a Disability Confident Employer and will provide reasonable adjustments to support your application and career. Our mission is to unleash the power of our people, including those with unique abilities.